The Effect of Maternal Warming During Cesarean Delivery on Neonatal Temperature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Neonatal axillary temperature at delivery
研究概览
简要总结
The purpose of this study to investigate whether using a special warming blanket during Cesarean delivery helps maintain a normal body temperature in the baby when compared to mothers that are not warmed (standard care at BC Women's Hospital). Doctors observed that some babies have low body temperatures when they are born by Cesarean delivery. Since baby temperatures are dependant on the temperatures of their mothers, we believe that keeping the mother warm during surgery with the use of a special warming blanket that is filled with warm air will result in the baby being warmer at birth.
详细描述
Maternal hypothermia during Cesarean delivery is predominately caused by a combination of neuraxial anesthesia and exposure of abdominal contents and skin to the low temperatures of the operating room (OR). Since maternal temperature and fetal temperature are intimately related, neonates experience hypothermia at birth due to maternal hypothermia. Neonatal hypothermia on admission to the Intensive Care Unit is an important determinant of morbidity and mortality, particularly in preterm neonates.
At BC Women's Hospital the majority of Cesarean deliveries are done under neuraxial anesthesia and the pediatricians have observed that some babies had suboptimal body temperatures at the time of Cesarean delivery. The pediatricians wanted to reverse this trend in neonatal hypothermia and requested that the OR temperature be increased to 25oC, more in line with World Health Organization (WHO) guidelines for delivery rooms. However, raising OR temperatures is usually not a comfortable option to the majority of staff working in this environment, therefore WHO recommendations are not followed.
Forced air warming is a common technique used during surgical procedures to maintain normothermia in anesthetized patients. A bi-layered blanket with multiple air channels is connected to a warming device that forces warm air between the layers of the blanket and ultimately around the patient. This device is effective in warming hypothermic patients or maintaining temperature in normothermic patients in a cool OR.
The studies on maternal warming at Cesarean delivery that have been published to date have shown inconsistent findings thus the subject warrants further investigation.
We postulate that actively warming mothers will prevent or decrease the risk of neonatal hypothermia at birth. In addition, we will examine whether active warming has a larger effect in the premature neonate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women undergoing elective cesarean delivery under spinal anesthesia or combined spinal epidural anesthesia
- •Greater than 28 weeks gestation
- •ASA 1 & 2 classification of health
- •Mothers presenting to the assessment or labour and delivery unit with ruptured membranes or early signs of labour, but not in active labour, who are not planned for a vaginal birth and who need an urgent cesarean delivery
- •Potential subjects need to be able to read and understand English unless independent (non-partner) translator available
排除标准
- •Mothers in active labour - 3cm or more dilated with regular coordinated contractions
- •ASA 3 or above
- •Emergency cesarean delivery for fetal heart rate abnormalities
- •Cesarean delivery under general anesthesia
- •Maternal age <19 years
- •Maternal infection
- •Mothers with a CSE where > 5ml of epidural local anesthetic is given prior to the delivery of the fetus
- •Mothers with vascular disease - with the exception of hypertension/pre-eclampsia
- •Mothers with Type I Diabetes Mellitus
- •Untreated hypothyroidism or hyperthyroidism
- •Mothers with a history or family history of malignant hyperthermia
- •Those who cannot understand English, and lack of consent
结局指标
主要结局
Neonatal axillary temperature at delivery
时间窗: During delivery
次要结局
未报告次要终点
